Sub-Incisional Pockets for Sealing Phacoemulsification Incisions: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Wound seal of participants assessed with the CCI-SIP 4-point ordinal scale by pressure with cotton tip pledget at post-operative day 1.
研究概览
简要总结
The main goal of the sub-incisional pocket (SIP) is to provide a wound seal option during corneal surgery. This retrospective cohort study aims to report the efficacy and safety of SIP among eyes undergoing routine cornea surgery as well as to determine factors that could be correlated with wound seal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years) participants
- •Patients undergoing primary phacoemulsification with clear corneal incision and in-the-bag intraocular acrylic lens
- •Uncomplicated cataract surgeries utilizing a 2.2 mm temporal clear corneal incision with sub-incisional stromal pocket.
排除标准
- •Medical records from patients with intraoperative complications requiring incisions or suturing
- •Prior surgery in the operative eye
- •Prior corneal disease or ocular surface disease
- •With an inadequate follow-up within 7 days after surgery
结局指标
主要结局
Wound seal of participants assessed with the CCI-SIP 4-point ordinal scale by pressure with cotton tip pledget at post-operative day 1.
时间窗: 6 Weeks
Clear corneal incision-Subincisional pocket (CCI-SIP) wound seals were graded on a 4-point ordinal scale: Grade 4, Fully formed AC after removal of all instrumentation with no hydration maneuvers; Grade 3, Flat AC after instrumentation removal, AC reformed after hydrating the side-port incisions only; Grade 2, Flat AC reformed after hydrating both side ports and SIP; and Grade 1, flat AC reformed after hydrating the side ports, SIP and CCI lateral walls. A higher wound grade denotes better wound sealability.
Change from 3 months pre-operation in astigmatism as measured by keratometry (diopter) at 6 weeks post-operation.
时间窗: 6 weeks
次要结局
未报告次要终点